Chembio receives FDA approvable letter for its rapid HIV tests

By Lisa Kerner

Erie, Pa., April 19 - Chembio Diagnostics, Inc. received an approvable letter from the Food and Drug Administration for its Sure Check HIV ½ and HIV ½ Stat-Pak rapid test pre-market applications, according to a news release.

The tests, completed in about 15 minutes, detect HIV-1 and HIV-2 antibodies in finger-stick whole blood, venous whole blood, serum and plasma.

"Estimates are that as much as 1/3 of those infected with HIV in the U.S. population are not aware of their HIV-positive status," president and chief executive officer Lawrence Siebert said in the release.

"We believe that these individuals are much likelier to access testing services if test results and counseling can be delivered at the point of care, rather than having to wait days or weeks for laboratory results."

Chembio expects the U.S. rapid HIV test professional market will exceed $50 million within the next couple of years.

Located in Medford, N.Y., Chembio develops rapid diagnostic tests for infectious diseases.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.